Abstract: A lancet-sampler system is configured to automatically remove a protective cover from a lancet and automatically unpack a test pad just prior to use. This minimizes the risk of injury and reduces the chance of cross-contamination between the lancet and the test pad. The lancet defines a capillary groove for drawing body fluid from the incision via capillary action and a sample transfer opening for collecting the fluid from the groove. A carrier tape is coupled to the lancet. The carrier tape includes a test pad for analyzing the fluid. The tape is folded around the test pad to form an airtight package. The test pad is located at a position to align with the sample transfer opening when the tape is unfolded. The protective cover covers a portion of the lancet, and when the tape is pulled, the protective cover is automatically pulled from the lancet.

Abstract: A closure system and methods of use are provided for use in sealing an opening in a body tissue, such as a vascular puncture site. A method of closing the opening in the body tissue can be performed with the closure system having a closure clip. The method can include positioning the closure clip in a first closure clip position adjacent to the opening in the body tissue such that a plurality of spikes of the closure clip are inserted into the tissue at a location outward from a central axis of the opening. Subsequently, the closure clip can be positioned in a second closure clip position such that the plurality of spikes are pulled inward toward the central axis of the opening so as to pull the tissue between the opening and each of the spikes together and close the opening.

Abstract: An integrated lancing test strip includes a test strip and a lancet packet coupled to the test strip. The lancet packet includes a sterility sheet enclosing a lancet to maintain the sterility of the lancet and prevent cross-contamination between the test strip and the lancet. The sterility sheet allows the lancet to be sterilized separately from the test strip. In one form, a firing mechanism has a blade that punctures and slits the sterility sheet during the firing cycle to reduce the chance of cross contamination between the lancet and the test strip prior to use. This allows an operator to load and subsequently remove an unused integrated lancing test strip without compromising the sterility of the lancet. The lancet includes an engagement opening in which the blade of the firing mechanism engages the lancet. The engagement opening is configured to reduce the chance of the blade becoming dull.

Abstract: A body fluid sampling device includes a firing mechanism that is configured to be automatically cocked and fired. In one form, the device includes an electric motor that is operable to cock the firing mechanism and fire an integrated lancet/sampling device to form an incision in skin. Subsequent to formation of the incision, the integrated lancet device is temporarily removed from the skin to promote bleeding from the incision. After a specified period of time, the integrated lancet device is then repositioned against the skin in order to collect a fluid sample.

Abstract: A lancet wheel having a rim with a plurality of lancets extending radially inward from the rim is dropped in a circular frame having a plurality of spokes forming a plurality of chambers for facilitating drop-in assembly of the modular lancet wheel with the frame. A test ring having a plurality of test sections is assembled on the frame such that one test section is located adjacent each lancet to form an integrated cartridge. Each lancet includes a lancet tip defining a capillary groove sized to collect a body fluid sample from the incision via capillary action. The lancet tip exits the chamber to form the incision in skin, the capillary groove collects the body fluid sample, the lancet tip retracts into the chamber, and a portion of the lancet contacts the test section to transfer the sample from the capillary groove to the test section to analyze the sample.

Abstract: A supply of lancets for a multi-use lancing device are carried by a tape and sequentially brought from a storage position to an activating position by advancing the tape around a bend. The lancets are non-circular in cross-section along their longitudinal lengths, and in their activating position they extend from the tape such that their sharp tips are available for lancing tissue. The carrying tape can be arranged in reel-to-reel format in a housing having a lancing opening. The lancets can be integral with the tape and activated to move the lancet through the lancing opening by moving the tape along its tape path or by translating a dedicated service loop of the tape. The lancets can also be independent from the tape and activated through the lancing opening by a separate lancing actuator. A test media can be included on the carrying tape and the housing can contain a sensor to yield an integrated lancing and testing device.

Abstract: An integrated lancing test strip includes a test strip and a lancet packet coupled to the test strip. The lancet packet includes a sterility sheet enclosing a lancet to maintain the sterility of the lancet and prevent cross-contamination between the test strip and the lancet. The sterility sheet allows the lancet to be sterilized separately from the test strip. The sterility sheet gives the integrated strip a low profile, which is attractive for packaging multiple integrated strips in cassettes, drums, magazines or the like. In one form, the integrated strip is loaded in a meter that includes an adjustment mechanism that adjusts the position of the test strip relative to the skin being sampled. This allows the user to adjust the position of the test strip so as to not apply excessive pressure against skin, which could hamper bleeding from the incision in the skin.

Abstract: Body fluid sampling device comprising a skin-piercing element having a collection zone for receiving body fluid. In one embodiment, the collection zone includes a plurality of holes, e.g., 3 or more holes, or 50 to 100 holes. The hole size may be small, e.g., having a diameter of 0.01 to 0.5 mm. The holes may or may not extend through the lancet. In some embodiments, the holes have a depth of 50 to 500 ?m. In other embodiments, the collection zone is porous, or is a roughened area. The collection zone can take up a very small volume of body fluid, e.g., 3 to 10 nL, in a very short time period, e.g., less than 0.5 seconds. In other embodiments, the device further comprises a fluid receiving means spaced apart from the collection zone so that body fluid in the collection zone will not contact the fluid receiving means initially.

Abstract: An integrated lancing test strip includes a test strip and a lancet packet coupled to the test strip. The lancet packet includes a sterility sheet enclosing a lancet to maintain the sterility of the lancet and prevent cross-contamination between the test strip and the lancet. The sterility sheet allows the lancet to be sterilized separately from the test strip. The sterility sheet gives the integrated strip a low profile, which is attractive for packaging multiple integrated strips in cassettes, drums, magazines or the like. In one form, the integrated strip is loaded in a meter that includes an adjustment mechanism that adjusts the position of the test strip relative to the skin being sampled. This allows the user to adjust the position of the test strip so as to not apply excessive pressure against skin, which could hamper bleeding from the incision in the skin.

Abstract: A bodily fluid sampling device includes a piercing device and a sensor enclosed in a housing. A cassette, which contains test media, is positioned proximal to the sensor so that the sensor is able to analyze a bodily fluid sample collected on the test media. The cassette includes a supply portion from which unused test media is supplied and a storage portion in which contaminated test media is stored after exposure to the bodily fluid. The cassette is adapted to collect a series of bodily fluid samples without requiring disposal of the test media.

Abstract: A bodily fluid sampling device includes a piercing device and a sensor enclosed in a housing. A cassette, which contains test media, is positioned proximal to the sensor so that the sensor is able to analyze a bodily fluid sample collected on the test media. The cassette includes a supply portion from which unused test media is supplied and a storage portion in which contaminated test media is stored after exposure to the bodily fluid. The cassette is adapted to collect a series of bodily fluid samples without requiring disposal of the test media.

Abstract: Body fluid sampling device comprising a skin-piercing element having a collection zone for receiving body fluid, and the device further comprising a fluid receiving means remote spaced apart from the collection zone so that body fluid in the collection zone will not contact the fluid receiving means initially. The collection zone takes up a very small volume of body fluid of about 10 to 500 nl in a very short time period of less than 0.5 seconds. The fluid receiving means may have a test zone for performing an analytical reaction. Fluid sample from the collection zone is automatically or manually transported to the fluid receiving means to contact the fluid with the test zone.

Abstract: An integrated lancing test strip includes a test strip and a lancet packet coupled to the test strip. The lancet packet includes a sterility sheet enclosing a lancet to maintain the sterility of the lancet and prevent cross-contamination between the test strip and the lancet. The sterility sheet allows the lancet to be sterilized separately from the test strip. The sterility sheet gives the integrated strip a low profile, which is attractive for packaging multiple integrated strips in cassettes, drums, magazines or the like. In one form, the integrated strip is loaded in a meter that includes an adjustment mechanism that adjusts the position of the test strip relative to the skin being sampled. This allows the user to adjust the position of the test strip so as to not apply excessive pressure against skin, which could hamper bleeding from the incision in the skin.

Abstract: A device for sampling body fluid, the device comprising, a main body, a lancet disposed within the main body, a carrier disposed within the main body fixedly attached to the lancet, a biasing means in communication with the lancet and the carrier, an annular space disposed within the main body adjacent the lancet, and a means for measuring a body fluid. Wherein the means for measuring the body fluid may include micro-porous test strips, an electronic testing device, an optical/reflectance testing measuring device, or a visual inspection.

Abstract: A bodily fluid sampling device includes a piercing device and a sensor enclosed in a housing. A cassette, which contains test media, is positioned proximal to the sensor so that the sensor is able to analyze a bodily fluid sample collected on the test media. The cassette includes a supply portion from which unused test media is supplied and a storage portion in which contaminated test media is stored after exposure to the bodily fluid. The cassette is adapted to collect a series of bodily fluid samples without requiring disposal of the test media.

Abstract: A disposable device for analyzing body fluid especially for blood sugar tests includes a container which can be inserted into a measuring apparatus, a sampling member provided in the container to pierce skin of a body part and sample body fluid, and a test member for receiving body fluid obtained by the skin-piercing. In one form, the test member is fixed in a retaining chamber of the container, and the sampling member is configured in the same retaining chamber such that it is separated at a distance from the test member in an initial state and is in contact with the test member to transfer body fluid in a transfer state after the skin-piercing.

Abstract: A bodily fluid sampling device is operable to lance with a precise depth and express fluid from both fingertip and alternate sites. In one form, the device is operable to adjust the penetration depth of the lancet into the skin. The bodily fluid sampling device includes a lancet adapted to form an incision in skin. A skin contacting member has an orifice through which the lancet extends when lancing the skin. The orifice has a first opening size that is sized to flatten the skin around the lancet during lancing. The orifice has a second opening size that is larger than the first opening size after the incision is formed to express fluid from the incision.

Abstract: A device for sampling body fluid, the device comprising, a main body, a lancet disposed within the main body, a carrier disposed within the main body fixedly attached to the lancet, a biasing means in communication with the lancet and the carrier, an annular space disposed within the main body adjacent the lancet, and a means for measuring a body fluid. Wherein the means for measuring the body fluid may include micro-porous test strips, an electronic testing device, an optical/reflectance testing measuring device, or a visual inspection.

Abstract: A device is constructed so as to define a capillary channel that draws a body fluid form a proximal portion of the capillary channel toward a distal portion. A counterbore defining a “ledge” not substantially normal to the center line of channel causes the meniscus of body fluid to be “biased” into a non-radially-symmetric shape. In one example, the bias draws the body fluid toward a testing element that is set into a groove in the main body of the device. In another example, hydrophilic and/or hydrophobic regions are created on or in device to produce the biasing effect. In certain configurations, device requires less blood to be drawn into the capillary channel for a successful test than if the biasing effect were not created.

Abstract: A lancet integrated test element (LIT) includes an incision forming member that has a cutting end configured to form an incision in tissue. A test element is attached to the incision forming member to test fluid from the incision. The test element has a sampling end with a sample opening through which the fluid is collected. The test element is bendable from a first state where the cutting end of the incision forming member is retracted from the sampling end of the test element to a second state where at least a portion of the cutting extends past the sampling end of the test element to form the incision in the tissue.